Manufacturing Engineer

Manufacturing Engineer Katalyst Healthcares & Life Sciences - 4.0 Danvers, MA Job Details Contract 4 hours ago Qualifications Inspection tools Audit report preparation Technical documentation ISO standards Engineering Regulatory compliance Mid-level 3 years Dimensional measurements Bachelor's degree in engineering Quality control documentation Continuous improvement Scientific protocols Precision measurement in machining Quality engineering Technical skills instruction Manufacturing Manufacturing company experience Test Planning (Quality assurance practices) Engineering validation

Full Job Description Job Description:

We are seeking a skilled Medical Device Manufacturing Engineer to support manufacturing validation, inspection methods, and quality documentation activities within a regulated medical device environment. The ideal candidate will have experience developing TMV protocols and reports, creating validation plans, interpreting engineering drawings and specifications, and supporting measurement system analysis activities. Candidates should also possess strong knowledge of inspection tools, ISO compliance, and medical device regulatory documentation.

Roles & Responsibilities:

Write clear TMV (Test Method Validation) protocols and reports. Create test procedures, acceptance criteria, and validation plans. Interpret test methods, engineering drawings, and product specifications. Apply Gage R&R (Repeatability and Reproducibility) methodologies for measurement system analysis. Select and utilize appropriate precision measurement tools such as vernier calipers, micrometers, and related inspection instruments. Collaborate with Engineering, Quality, Operations, and R D teams to support manufacturing and validation activities. Produce audit-ready documentation in compliance with ISO standards and medical device regulatory requirements. Train operators, engineers, and quality personnel on validated inspection methods and best practices. Support continuous improvement initiatives related to manufacturing quality and process validation.

Education & Experience:

Bachelor's degree in engineering, Manufacturing, Quality, or related technical field preferred. 3+ years of experience in medical device manufacturing, validation, or quality engineering environment. Equivalent combination of education and relevant industry experience will also be considered.